FDA Medical Device Recalls (openFDA)
Neocis, Inc.: DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
- Recall number
- Z-0929-2021
- Recalling firm
- Neocis, Inc.
- Product
- DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
- Status
- Terminated
- Initiated
- 2020-10-30
- Posted
- not on file
- Terminated
- 2021-08-11
- Reason
- The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
- Root cause
- Process control
- Action
- The firm initiated the recall by letter on 10/30/2020 via UPS overnight delivery. The letter explains the issue, refers to the original recall and requests that the consignee set aside any affected product. Neocis Field Personnel will inspect the devices and return them to the manufacturing facility.
- Quantity
- 100 units
- Distribution
- OH, FL, CT, MA, AZ PA, NY
- Lot, serial or model codes
- Work Order (Lot) Number 1573
- 510(k) numbers
- K173402
- PMA numbers
- not on file
- Product code
- PLV
- Firm FEI
- 3012787974
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28